Operator I - Contract

Under close supervision, the role involves performing a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components. Support divisional initiatives and comply with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.

Title - Operator I
Shift - 6am to 2: 30 pm
Location - Westfield IN
Duration - 12 months

Position Summary
This position is responsible for the production of high-quality medical devices within a manufacturing cell. Under close supervision, the role involves performing a combination of assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device components. Assignments are routine and carried out in accordance with established procedures, with work subject to continuous review.

Key Responsibilities

• Perform assembly, repair, and testing tasks following standardized procedures.
• Ensure all job documentation related to cell operations is accurate and up to date.
• Maintain clear and effective communication of ideas, issues, and solutions with all levels of manufacturing management, both verbally and in writing.
• Foster a positive and professional attitude when interacting with internal and external stakeholders, including visitors.
• Adhere strictly to safety guidelines and use appropriate protective equipment during all operations.
• Participate in continuous improvement and quality initiatives to enhance production efficiency and meet quality and profitability targets.
• Maintain accurate records to ensure traceability of all parts and proper documentation of quality-related information.
• Demonstrate a basic understanding of Lean Manufacturing principles.
• Collaborate with supervisors/managers to establish and monitor individual and team performance goals.
• Support divisional initiatives and comply with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.

Qualifications and Skills

• High school diploma or equivalent required.
• Ability to read, understand, and follow written procedures and verbal instructions.
• Proficiency in using electronic data collection systems and standard computer software.
• Strong organizational skills with the ability to prioritize tasks effectively.
• Manual dexterity to handle small components and parts.
• Ability to make sound decisions with minimal supervision.

Dress Code and Workplace Requirements
To maintain product integrity and safety within the production environment, all personnel must adhere to strict dress code standards:

• Clothing must be clean, non-shedding, and free of loose fibers, frayed hems, or contaminants.
• Items such as tassels, fringes, glitter, or sequins are not permitted.
• Loose-knit garments, fleece, sweaters, or similar materials are prohibited.
• Clothing must fit entirely under required lab coats or gowns; sleeves and necklines must not extend beyond protective garments.
• Head coverings must comply with hygiene standards and be fully contained under required protective coverings.
• Loose-fitting clothing is not allowed around machinery or open heat sources.
• Closed-toe, low-heel shoes (under 2 inches) must be worn at all times; sandals, open shoes, or footwear exposing toes are prohibited.
• Changing shoes is only permitted in designated gowning areas.
• Appropriate full-body coverage is required; sleeveless tops, short garments, or exposed skin are not permitted.
• Nail polish, artificial nails, and similar coatings are prohibited.
• Jewelry and piercings that cannot be fully covered or may compromise safety are not allowed.
• Makeup and scented personal products are not permitted, except deodorant; lip balm may be used outside production areas prior to handwashing.
• Lotions must not be applied after handwashing.
• Any cuts or wounds must be properly covered with a bandage.
• Attire must be professional and non-offensive at all times.

Keywords: assembler, operator, assembly, medical device , repair , manufacturing

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